SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report: October 24, 1996
MEDIMMUNE, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 0-19131
Delaware 52-1555759
(State of Incorporation) (I.R.S. Employer
Identification No.)
35 West Watkins Mill Road, Gaithersburg, MD 20878
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (301) 417-0770
No Exhibits are being filed with this report
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained on the following press
release dated October 24, 1996.
MEDIMMUNE REPORTS 63 PERCENT INCREASE IN PRODUCT SALES
Gaithersburg, MD, October 24, 1996 - MedImmune, Inc. (Nasdaq:MEDI) today
reported that total product sales for the nine months ended September 30,
1996 increased 63 percent to $18.1 million from $11.1 million in the same
period of 1995.
Total revenues for the first nine months of 1996 increased by 13 percent to
$23.1 million with a net loss of $18.8 million or $0.90 per share on 20.8
million shares compared to revenues of $20.5 million and a net loss of
$14.1 million or $0.90 per share on 15.6 million shares in the same period
of 1995. Total revenues for the quarter were $4.8 million which included
$4.1 million in sales of CytoGam ($4.9 million prior to a one-time charge
to reflect potential lost revenues resulting from the declared bankruptcy
of a pharmaceutical wholesaler), $0.5 million sales of RespiGam and $0.1
million in contract revenues. During the third quarter, total product
sales increased by 41 percent from $3.8 million in the third quarter 1995
to $5.4 million in the third quarter 1996 prior to the one-time charge.
Net loss in the third quarter was $10.2 million or $0.47 per share. At
September 30, 1996 MedImmune had cash and marketable securities of $124.0
million.
"As we enter the fourth quarter, we are preparing for the commencement of
this year's RSV season and the full launch for our second product,
RespiGam," commented David M. Mott, President and Chief Operating Officer
of MedImmune.
In preparation for the launch of RespiGam, MedImmune has focused on
obtaining third party payor approvals as well as managed care and hospital
acceptance. To date, 50 of 51 Medicaid programs have confirmed coverage
and 81 of the largest managed care organizations have approved RespiGam for
reimbursement. In addition, a significant number of the largest neonatal
and pediatric hospitals have added RespiGam to their formularies and
developed protocols for its use. Investigators from the Company's clinical
trials have conducted 220 speakers programs at major teaching hospitals
across the United States to educate physicians, nurses and hospital
administrators about RespiGam.
During the third quarter, one of MedImmune's largest customers, a
pharmaceutical wholesaler, declared Chapter 11 bankruptcy protection.
Accordingly, MedImmune took a charge against product sales in the quarter
of approximately $740,000 reflecting inventory previously sold to this
wholesaler. In addition, MedImmune's sale of product to this wholesaler
was interrupted during the third quarter. The Company does not expect the
status of this wholesaler to negatively impact future quarterly results.
MedImmune, Inc. is a biotechnology company focused on developing and
marketing products for the prevention and treatment of infectious diseases
and for use in transplantation medicine. CytoGam and RespiGam are
polyclonal antibody products enriched in antibodies against cytomegalovirus
(CMV) and respiratory syncytial virus (RSV), respectively. CytoGam is used
for attenuation of primary CMV disease associated with kidney
transplantation, and RespiGam is used to prevent serious RSV disease, the
leading cause of bronchiolitis and pneumonia in certain high-risk children.
CytoGam and RespiGam are manufactured by Massachusetts Public Health
Biologic Laboratories. MedImmune markets CytoGam and RespiGam through its
hospital-based sales force and has six new product candidates in clinical
trials. MedImmune is located in Gaithersburg, MD.
This announcement may contain, in addition to historical information,
certain forward looking statements that involve risks and uncertainties.
Such statements reflect management's current views and are based on certain
assumptions. Actual results could differ materially from those currently
anticipated as a result of a number of factors, including risks and
uncertainties discussed in the Company's filings with the U.S. Securities
and Exchange Commission.
CytoGam is a registered trademark and
RespiGam is a trademark of the Company.
- Table Follows -
MedImmune, Inc.
Selected Financial Information
(in thousands, except per share data)
Condensed Statements of Operations (Unaudited)
<TABLE>
<S> <C> <C> <C> <C>
Three Months Nine Months
Ended September 30, Ended September 30,
1996 1995 1996 1995
--------- --------- --------- ---------
Revenues
Product sales $ 4,632 $ 3,821 $ 18,086 $ 11,121
Contracts 148 2,843 5,055 9,330
--------- --------- --------- ---------
4,780 6,664 23,141 20,451
--------- --------- --------- ---------
Costs and expenses
Cost of sales 2,924 2,295 11,046 7,763
Research and development 7,817 5,965 20,059 20,524
Selling, administrative 5,043 2,511 13,602 7,169
and general
--------- --------- --------- ---------
15,784 10,771 44,707 35,456
--------- --------- --------- ---------
Interest income, net 842 361 2,796 924
--------- --------- --------- ---------
Net loss $(10,162) $ (3,746) $ (18,770) $(14,081)
========= ========= ========= =========
Loss per share $ (0.47) $ (0.22) $ (0.90) $ (0.90)
========= ========= ========= =========
Shares used in computing loss 21,656 16,722 20,782 15,600
per share
========= ========= ========= =========
</TABLE>
Condensed Balance Sheets
<TABLE>
<S> <C> <C>
September 30, 1996 December 31,1995
------------------ ------------------
(unaudited)
Assets:
Cash and marketable securities $ 124,012 $ 38,039
Trade and contract receivables, net 7,080 3,919
Inventory, net 7,652 6,027
Property and equipment, net 18,807 8,255
Other assets 3,140 1,092
--------- ---------
$ 160,691 $ 57,332
========= =========
Liabilities and shareholders' equity
Accounts payable $ 2,614 $ 2,318
Accrued expenses 8,147 6,538
Long term debt 63,328 1,984
Other liabilities 3,059 2,713
Shareholders' equity 83,543 43,779
--------- ---------
$ 160,691 $ 57,332
========= =========
Common shares outstanding 21,657 17,706
========= =========
</TABLE>
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
MEDIMMUNE, INC.
Registrant)
Date: October 24, 1996 David M. Mott
President and Chief Operating Officer
(Principal financial and accounting
officer)
